Overview

This trial is active, not recruiting.

Condition social anxiety disorder
Treatments vilazodone, placebo
Sponsor The Medical Research Network
Collaborator Forest Laboratories
Start date October 2012
End date March 2014
Trial size 30 participants
Trial identifier NCT01712321, VII-IT-07

Summary

The purpose of this study is to determine whether Vilazodone is effective in the treatment of symptoms of Social Anxiety Disorder among adults.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks
vilazodone Viibryd
Vilazodone 20mg or 40mg taken once daily by mouth
(Placebo Comparator)
Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks
placebo Matching placebo
Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth

Primary Outcomes

Measure
Change in Liebowitz Social Anxiety Scale (LSAS) - total score
time frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks

Secondary Outcomes

Measure
Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2
time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in the Clinical Global Impression of Severity of Illness score
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change on the LSAS anxiety and avoidance subscales
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Depression scale total
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Change in Hamilton Anxiety scale total
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
Subject-assessed responder rate
time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Diagnosis of Social Anxiety Disorder, generalized subtype - LSAS total score of 70 at visits 1 and 2 Exclusion Criteria: - Lifetime history of Bipolar disorder or Schizophrenia - Current suicidal risk - Current unstable medical condition

Additional Information

Official title Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study
Principal investigator Michael R. Liebowitz, MD
Description The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at least one post randomization visit where efficacy evaluations are conducted.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by The Medical Research Network.